FDA.reportPublic FDA data

Olympus

Primary DI
04042761030267
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WA05971A
Catalog number
WA05971A
Device description
Insert tray, large
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033222000OLYMPUS STERILIZATION TRAYSOlympus Winter & Ibe GmbH2004-08-02KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761030267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761030267040427610302674042761030267

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
316957240
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761082297OlympusWA03300AWA03300A2016-09-22
04042761082303OlympusWA03310AWA03310A2016-09-22
14042761083369OlympusWT645010WT6450102023-06-20
04042761083324OlympusWT806450WT8064502023-01-27
04042761081757OlympusWA97013AWA97013A2023-06-20
04042761083102OlympusWT2187002023-06-20
04042761083119OlympusWT2187052023-06-20
04042761083126OlympusWT2187112023-06-20
04042761083133OlympusWT2187202023-06-20
04042761083140OlympusWT6304002023-06-20
04042761083164OlympusWT6400212023-06-20
04042761083171OlympusWT645001WT6450012023-06-20
04042761083188OlympusWT645006WT6450062023-06-20
04042761083218OlympusWT645013WT6450132023-06-20
04042761083225OlympusWT645016WT6450162023-06-20
04042761083232OlympusWT645017WT6450172023-06-20
04042761083256OlympusWT645020WT6450202023-06-20
04042761083263OlympusWT645025WT6450252023-06-20
04042761083270OlympusWT645030WT6450302023-06-20
04042761083287OlympusWT645031WT6450312023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817766026355X-Series CaseTecometKCT2026-09-04
00817766026362X-Series CaseTecometKCT2026-09-04
00817766026379X-Series CaseTecometKCT2026-09-04
00817766026386X-Series CaseTecometKCT2026-09-04
00817766026393X-Series CaseTecometKCT2026-09-04
00817766026430X-Series CaseTecometKCT2026-09-04
00817766026447X-Series CaseTecometKCT2026-09-04
00385640094146INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094153INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094160INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094177INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094139INSTRUSAFESummit Medical, Inc.KCT2026-08-26
00724995234232V. MuellerSteris CorporationKCT2026-08-26
00724995234249V. MuellerSteris CorporationKCT2026-08-26
00724995234256V. MuellerSteris CorporationKCT2026-08-26
00724995234263V. MuellerSteris CorporationKCT2026-08-26
00724995234270V. MuellerSteris CorporationKCT2026-08-26
00724995234287V. MuellerSteris CorporationKCT2026-08-26
00724995234294V. MuellerSteris CorporationKCT2026-08-26
00724995234300V. MuellerSteris CorporationKCT2026-08-26
00724995234317V. MuellerSteris CorporationKCT2026-08-26
00724995234324V. MuellerSteris CorporationKCT2026-08-26
00724995234331V. MuellerSteris CorporationKCT2026-08-26
00724995234348V. MuellerSteris CorporationKCT2026-08-26
00724995234355V. MuellerSteris CorporationKCT2026-08-26
00724995234362V. MuellerSteris CorporationKCT2026-08-26
00724995234379V. MuellerSteris CorporationKCT2026-08-26
00724995234386V. MuellerSteris CorporationKCT2026-08-26
00724995234393V. MuellerSteris CorporationKCT2026-08-26
00724995234409V. MuellerSteris CorporationKCT2026-08-26